New Guidelines Could Add 12.8 Million New Statin Users

The new American College of Cardiology–American Heart Association (ACC-AHA) guidelines for managing cholesterol—if adhered to strictly—would increase the number of adults eligible for statin therapy by 12.8 million, according to the results of a study published in the New England Journal of Medicine.[1] This increase would be seen mostly among older adults without cardiovascular disease.

Statins are cholesterol-lowering drugs and are the most commonly prescribed class of prescription drugs in the United States. Some studies have suggested that in addition to their cardiovascular effects, statins may help to reduce the risk of certain cancers, including prostate cancer and colorectal cancer.[2][3] However, other studies have demonstrated little evidence that statins reduce risk.[4][5]

In November 2013, the ACC-AHA released new cholesterol management guidelines that were substantially modified from the previous 2007 guidelines (known as the Third Adult Treatment Panel—or ATP III—of the National Cholesterol Education Program.)[6] Among patients with known cardiovascular disease, the new guidelines expand the treatment recommendation to all adults, regardless of the LDL cholesterol level. For primary prevention, whereas both sets of guidelines recommend statin therapy for patients with an LDL cholesterol level of 190 mg per deciliter or higher, the new guidelines also recommend statin therapy in all individuals who have an LDL cholesterol level of 70 mg per deciliter or higher and who also have either diabetes or a 10-year risk of cardiovascular disease of 7.5% or more, as estimated on the basis of new pooled-cohort equations

Researchers used data from the National Health and Nutrition Examination Surveys (NHANES) to estimate the number of statin users based on the new guidelines, as compared with the ATP-III guidelines. They used fasting sample data collected between 2005 and 2010 from a study sample of 3,773 participants.

The results indicated that the new guidelines would increase the number of U.S. adults eligible for statin therapy from 43.2 million to 56.0 million. Most of this increase (10.4 million of 12.8 million) would occur among adults without cardiovascular disease. The percentage of 60-75-year-olds without cardiovascular disease that would become eligible would increase dramatically—from 30.4 percent to 87.4 percent among men and from 21.2 percent to 53.6 percent among women.

The largest increase would occur among adults who would be classified on the basis of their 10-year risk of a cardiovascular event. The new guidelines would include 15.1 million adults in this category, whereas the old ATP-III guidelines included 6.9 million.

The new guidelines place more emphasis on 10-year projected risk, whereas the old ones focus more on LDL cholesterol levels. The researchers concluded that the new guidelines would substantially increase the number of adults between ages 60 and 75 who were eligible for statin therapy. The majority of these new users would be for primary prevention.

[6] Stone NJ, Robinson J, Lichtenstein AH, et al: 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology. Published early online November 2013. doi:10.1016/j.jacc.2013.11.002